A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT06863961
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afimkibart — DRUG
    Afimkibart will be administered as SC injection.
  • Placebo — DRUG
    Placebo will be administered as SC injection.

Study Details

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Key Dates

Start date
Apr 1, 2025
Status verified
May 2026
Primary completion
Jul 22, 2026
Completion
Feb 3, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afimkibart Group I
    Participants will receive afimkibart via subcutaneous (SC) injection.
  • Experimental: Afimkibart Group II
    Participants will receive afimkibart via SC injection.
  • Experimental: Afimkibart Group III
    Participants will receive afimkibart via SC injection.
  • Placebo Comparator: Placebo
    Participants will receive placebo via SC injection.

Primary Outcome Measure

Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (25)

FacilityCityStateZIPSite coordinators
First OC DermatologyFountain ValleyCalifornia92708-
The Center for Dermatology Clinical ResearchFremontCalifornia94538-
Dermatology Research AssociateLos AngelesCalifornia90045-
University of California Los AngelesLos AngelesCalifornia90024-
Suncoast Research Associates LLC - ERN - PPDSDoralFlorida33172-
Olympian Clinical ResearchTampaFlorida33615-
Hamilton Research, LLCAlpharettaGeorgia30022-
Dermatology Affiliates Research Institute, LLCAtlantaGeorgia30305-
Dawes Fretzin Clinical Res LLCIndianapolisIndiana46250-
Southern Indiana Clinical TrialsNew AlbanyIndiana47150-
Revival Research Institute, LLCTroyMichigan48084-
Regents of the University of MinnesotaMinneapolisMinnesota55455-
Care Access Research - HobokenHobokenNew Jersey07030-
Forest Hill Dermatology GroupKew GardensNew York11415-
Weill Cornell MedicineNew YorkNew York10075-
Centricity Research DublinColumbusOhio43213-
DOCS Clinical Research - SpringfieldSpringfieldOhio45505-
Central Sooner ResearchOklahoma CityOklahoma73170-
Oregon Health & Science UniversityPortlandOregon97239-
Best Skin Research LLCCamp HillPennsylvania17011-
Arlington Research CenterArlingtonTexas76011-
Modern Research AssociatesDallasTexas75231-
Reveal Research InstituteDallasTexas75235-
Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLCSan AntonioTexas78213-
Care Access Research - ArlingtonArlingtonVirginia22206-

Find similar trials in Fountain Valley, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
First OC Dermatology· Fountain Valley, CAThe Center for Dermatology Clinical Research· Fremont, CADermatology Research Associate· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CASuncoast Research Associates LLC - ERN - PPDS· Doral, FLOlympian Clinical Research· Tampa, FL

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